Tips for Medical Device Manufacturers to Prepare for the Revised 60601

Dec. 19, 2011 - PRLog -- Werner Kexel, Managing Director, Eurocat and BSI, joins IQPC to discuss the 3rd revision to the standards guideline 60601 and tips for medical device manufacturers on how to prepare for the changes.

IQPC: Werner, thanks very much for joining us today to provide a snapshot of what you’ll be discussing. So, first of all, Werner, you’re the head of what were originally two separate notified body organisations, BSI and Eurocat, with an accordingly large network of many medical device manufacturers who must ask you questions all the time. What is the one big software-related question or issue that comes up more than any other?

W Kexel: At the moment, we get mostly the question not regarding standards of software products. The main question is, is my software a medical device? If so, which classification does it have?

IQPC: How can the manufacturers solve this big issue?

W Kexel: First, they have to do two things: think about their software or their software-containing medical device and what is the intended purpose with regard to a more medical purpose; then, if it is defined, to compare it with the legal definition of the medical device directive and the definitions there and look at whether it is a medical device or not.




The 2nd Annual Software Design for Medical Devices Europe will take place from 31 January - 02 February 2012, in Munich, Germany. For info please visit: www.sdmdeurope.com, call our enquiries team on 0207 036 1300 or email: enquire@iqpc.co.uk.

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IQPC
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